Australian Firm Receives FDA Approval for ‘Breakthrough’ COVID Test

Washington: Australian diagnostics company Ellume has won approval from US regulators to sell the first rapid at-home COVID-19 tests that don’t require a prescription.

The Brisbane-based company was granted an emergency use authorisation on Wednesday (AEDT) by the US Food and Drug Administration (FDA) to sell its over-the-counter tests.

Stephen Hahn, the head of the FDA, hailed the authorisation as “a major milestone in diagnostic testing for COVID-19”.

Alongside vaccinations, health experts believe rapid at-home testing will provide a crucial tool to bring the pandemic under control. Read more…..


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